Phillips Natalie, Askin Geoffrey N, Davis Gavin A, O'Brien Sharon, Borland Meredith L, Williams Amanda, Kochar Amit, John-Denny Blessy, Watson Sarah, George Shane, Davison Michelle, Dalziel Stuart, Tan Eunicia, Chong Shu-Ling, Craig Simon, Rao Arjun, Donath Susan M, Selman Chris J, Goergen Stacy, Wilson Catherine L, Singh Sonia, Kuppermann Nathan, Leonard Julie C, Babl Franz E
Emergency Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia
Biomechanics and Spine Research Group, School of Mechanical, Medical and Process Engineering, Queensland University of Technology, Brisbane, Queensland, Australia.
BMJ Open. 2025 May 2;15(5):e096294. doi: 10.1136/bmjopen-2024-096294.
Paediatric cervical spine injury (CSI) is uncommon but can have devastating consequences. Many children, however, present to emergency departments (EDs) for the assessment of possible CSI. While imaging can be used to determine the presence of injuries, these tests are not without risks and costs, including exposure to radiation and associated life-time cancer risks. Clinical decision rules (CDRs) to guide imaging decisions exist, although two of the existing rules, the National Emergency X-Radiography Low Risk Criteria and the Canadian C-Spine Rule (CCR), focus on adults and a newly developed paediatric rule from the Pediatric Emergency Care Applied Research Network (PECARN) is yet to be externally validated. This study aims to externally validate these three CDRs in children.
This is a multicentre prospective observational study of children younger than 16 years presenting with possible CSI following blunt trauma to 1 of 14 EDs across Australia, New Zealand and Singapore. Data will be collected on presenting features (history, injury mechanism, physical examination findings) and management (diagnostic imaging, admission, interventions, outcomes). The performance accuracy (sensitivity, specificity, negative and positive predictive values) of three existing CDRs in identifying children with study-defined CSIs and the specific CDR defined outcomes will be determined, along with multiple secondary outcomes including CSI epidemiology, investigations and management of possible CSI.
Ethics approval for the study was received from the Royal Children's Hospital Melbourne Human Research Ethics Committee in Australia (HREC/69436/RCHM-2020) with additional approvals from the New Zealand Human and Disability Ethics Committee and the SingHealth Centralised Institutional Review Board. Findings will be disseminated through peer-reviewed publications and future management guidelines.
Registration with the Australian New Zealand Clinical Trials Registry prior to the commencement of participant recruitment (ACTRN12621001050842). 50% of expected patients have been enrolled to date.
小儿颈椎损伤（CSI）并不常见，但可能会产生严重后果。然而，许多儿童因可能存在的CSI而前往急诊科（ED）就诊。虽然影像学检查可用于确定损伤的存在，但这些检查并非没有风险和成本，包括辐射暴露以及相关的终生患癌风险。尽管存在指导影像学检查决策的临床决策规则（CDR），但现有的两条规则，即国家急诊X线摄影低风险标准和加拿大颈椎规则（CCR），主要针对成年人，而儿科急诊护理应用研究网络（PECARN）新制定的儿科规则尚未经过外部验证。本研究旨在对这三条CDR在儿童中的应用进行外部验证。
这是一项多中心前瞻性观察性研究，研究对象为澳大利亚、新西兰和新加坡14家急诊科中因钝性创伤而可能存在CSI的16岁以下儿童。将收集患者的就诊特征（病史、损伤机制、体格检查结果）以及治疗情况（诊断性影像学检查、住院、干预措施、预后）。将确定三条现有CDR在识别符合研究定义的CSI儿童方面的性能准确性（敏感性、特异性、阴性和阳性预测值）以及特定CDR定义的预后，同时还将确定多个次要结局，包括CSI的流行病学、可能的CSI的检查和治疗情况。
该研究已获得澳大利亚墨尔本皇家儿童医院人类研究伦理委员会（HREC/69436/RCHM - 2020）的伦理批准，并获得了新西兰人类与残疾伦理委员会以及新加坡健康集团集中机构审查委员会的额外批准。研究结果将通过同行评审出版物和未来的管理指南进行传播。
在招募参与者之前已在澳大利亚新西兰临床试验注册中心注册（ACTRN12621001050842）。截至目前，已招募了预期患者的50%。
